DURC/PEPP Policy - Frequently Asked Questions:, Why should I care about complying with the DURC/PEPP Policy?, Awareness of the DURC (Dual Use Research of Concern) and PEPP (Pathogens with Enhanced Pandemic Potential) Policy is essential because research involv, How do I know if my research falls under the DURC/PEPP Policy?, Your research falls under the DURC/PEPP Policy if it involves certain biological materials and is reasonably anticipated to produce risky experimental, What do I need to do to comply with this policy?, If your research involves the use of biological agents, take the following steps to assist with compliance:Self-assess your research to see if it meet, Who is the ICDUR?, The ICDUR is the Institutional Contact for Dual Use Research.Dr. Antony Schwartz, the Director of the Biological Safety Division and the Institutional, What is the IRE?, The IRE is the Institutional Review Entity. At Duke, the Institutional Biosafety Review Committee (IBRC) serves as the IRE.It is a committee at Duke t, Who can help me if I have more questions or concerns?, The Institutional Contact for Dual Use Research (ICDUR) is available to help answer any questions or address concerns that you may have regarding DURC, What are considered ‘Biological Agents’ according to the policy?, “Biological agents” are any microorganism (including, but not limited to, bacteria, viruses, fungi, or protozoa), infectious material, or any naturall, What does ‘Reasonably Anticipated’ mean according to the policy?, “Reasonably anticipated” describes an assessment of an outcome such that, generally, individuals with scientific expertise relevant to the research in, What is Dual Use Research?, “Dual use research” is research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be uti, What is Dual Use Research of Concern?, “Dual use research of concern (DURC)” is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowled, What is a Pathogen with Pandemic Potential?, “Pathogen with pandemic potential (PPP)” is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely, What is a Pathogen with Enhanced Pandemic Potential?, “Pathogen with enhanced pandemic potential (PEPP)” is a type of pathogen with pandemic potential (PPP) resulting from experiments that enhance a patho, What is Category 1 and Category 2 research?, Category 1 research involves specified biological materials and experiments that could increase transmissibility, virulence, or other dangerous traits, What are the biological materials covered under Category 1 (DURC) research?, BacteriaBacillus anthracisBacillus anthracis Pasteur strainBacillus cereus Biovar anthracisBartonellaBotulinum neurotoxin producing species of Clostri, Which Risk Group 3 biological materials are excluded from the Policy?, Coccidioides immitisCoccidioides posadasiiHistoplasma capsulatumHistoplasma capsulatum var. DuboisiiHuman immunodeficiency viruses (HIV) types 1 and 2, What are the biological materials covered under Category 2 (PEPP) research?, Category 2 research involves pathogens with pandemic potential (PPPs) — either existing or those created or modified in ways that could make them more

Guidance & Policies, Duke DURC/PEPP Policy, External Resources, USG DURC/PEPP PolicyPolicy Implementation Guide, Forms and Templates, Risk Benefit AssessmentRisk Mitigation Plan, Related Information, Institutional Biosafety CommitteeSelect Agents & ToxinsNIH Guidelines for Recombinant and Synthetic Nucleic AcidsBiological Materials Reporting System